Regulatory Affairs Manager

Our company brings product innovation and quality to over-the-counter healthcare products to better improve the lives of our customers and their families. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter healthcare products in North America that continually improves and creates products that match the ever-changing lifestyles and needs of people globally.

We offer medical, dental, vision, life, short and long term disability insurance, and a 401(k) retirement plan with a recently enhanced Company match.
Our time-off programs are fairly typical, but employees do enjoy the week between Christmas and New Year's Day as a paid time-off benefit that doesn't get charged against vacation.
Competitive Salary + 20% Bonus for this role
Generous PTO
Other Perks:

• Snacks
• In-house gym

Hybrid: Tarrytown, NY

The Manager of Regulatory Affairs will report to the Sr. Director, Regulatory Affairs and, under the direction and guidance of the Sr. Director, will ensure the regulatory compliance of our products throughout the product development cycle and monitor regulatory developments that may impact the business. Product categories include OTC Medical Devices, OTC Drugs, Cosmetics, Dietary Supplements and EPA-regulated pesticides.

Major Responsibilities/Activities

• Foster close cooperative relationships with all functions in the company relative to regulatory compliance, including working with Product Development, Package Development, Legal, Quality Assurance and Marketing to execute all initiatives for assigned brands. (40%)
• Provide regulatory guidance to product development teams for assigned brands, including claim substantiation, label reviews and advice on regulatory submissions. (25%)
• Maintain and prepare NDA supplements and/or 510(k) applications as well as other regulatory documentation for assigned brands and products. (15%)
• Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company’s Quality System, external regulatory standards (e.g., ISO 13485), and relevant regulations. (10%)
• Monitor global regulatory developments affecting products through participation in industry associations, monitoring of newsletters and government websites and other methods, and communicate significant issues to management. Ensure that the activities of assigned industry task forces and committees reflect priorities. (10%)

Minimum Requirements
EDUCATION/CERTIFICATION:

• Bachelor's Degree in scientific or health-related field; Master's degree preferred

REQUIRED KNOWLEDGE:

• Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred
• Strong knowledge of OTC drug and device regulations, including labeling requirements
• Working knowledge of U.S. clinical research and claims support
• Excellent written and verbal communication skills
• Demonstrated ability to work with people in an effective and positive manner

EXPERIENCE REQUIRED:

• 6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs
• Drug or medical device submission and/or maintenance experience

The Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics, Packaging, Product Development, Legal and Marketing functions:

• Serve as the regulatory representative on identified product development teams
• Create or review U.S. & Canada regulatory submissions that meet company and regulatory agency requirements
• Develop and implement company and departmental SOPs and provide training/compliance
• Propose and meet realistic timelines for regulatory submissions and approvals
• Keep up to date on changes in regulatory requirements related to OTC drug, device, and dietary supplement regulations and communicate these changes within company
• Represent company on assigned industry task forces and ensure that company needs are addressed
• Improve work processes for continued regulatory compliance and departmental efficiencies
• Ensure compliance with applicable U.S. & Canada regulations, laws, and standards